Phase 1
Completed N=114
A Study Comparing the Pharmacokinetic Similarity of MB02-SP, MB02-DM and US Licensed-Avastin®.
Healthy Volunteers
Source: ClinicalTrials.gov NCT04408989 ↗
Enrolled (actual)
114
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcomePrimary: Pharmacokinetics (PK) - (AUC[0-∞]) — 7500000; 8000000; 7520000 h*ng/ml
Summary
Randomized, double blind, parallel group, single dose, 3 arm study to investigate and compare the PK, safety and immunogenicity profile of MB02-DM with MB02-SP and US-Avastin® in healthy male subjects.
During the course of the study, the similarity in pharmacokinetics will be assessed by sampling the levels of drug in the blood, and by comparing these levels among the different administration arms. Safety, tolerability, and immunologic response to the administered drugs will also be evaluated throughout.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics (PK) - (AUC[0-∞]) |
7500000; 8000000; 7520000 | — |
| PRIMARY Pharmacokinetics (PK) - (Cmax) |
25600; 27400; 26100 | — |
| SECONDARY Other PK Parameters (Tmax) |
4.02; 5.00; 5.00 | — |
| SECONDARY Other PK Parameters (AUC[0 t]) |
7010000; 7550000; 7110000 | — |
| SECONDARY Other PK Parameters (CL) |
0.0103; 0.00975; 0.0104 | — |
| SECONDARY Other PK Parameters (t1/2) |
390; 393; 396 | — |
| SECONDARY Immunogenicity |
8; 13; 9; 0; 0; 0 | — |
| SECONDARY Safety (Number of Participants Reporting Treatment-related Adverse Events) |
24; 23; 29; 0; 0; 0 | — |
| SECONDARY Safety (Treatment-related Adverse Events) |
42; 58; 59; 12; 9; 6 | — |
Eligibility Criteria
Inclusion Criteria
- Males of any race, between 18 and 55 years of age, inclusive, at Screening.
- Body mass index between 18.5 and 29.9 kg/m2, inclusive, at Screening.
- Total body weight between 50 and 95 kg, inclusive, at Screening.
- In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital sign measurements, and clinical laboratory evaluations (congenital non-haemolytic hyperbilirubinemia [eg, Gilbert's syndrome] is acceptable) at Screening or Check-in as assessed by the Investigator (or designee).
- Relevant clinical laboratory evaluations of haematology, coagulation, urinalysis and clinical chemistry within normal range at Screening and Check in as follows. A single repeat test will be allowed at each timepoint.
- Absolute neutrophil count ≥1.5 × 109 L
- Platelet count ≥100 × 109 L
- Haemoglobin >10 g/dl
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5 x ULN
- Alkaline phosphatase (ALP) ≤1.5 × ULN
- Total bilirubin 35 g/L
- Low density lipoprotein cholesterol ≤ 4.9 mmol/L
- High density lipoprotein cholesterol ≥ 0.85 mmol/L
- Creatine kinase (CK) 24 units per week. One unit of alcohol equals ½ pint (285 mL) of beer or lager, 1 glass (125 mL) of wine, or 1/6 gill (25 mL) of spirits.
- Positive hepatitis panel, positive human immunodeficiency test. Subjects whose results are compatible with prior immunisation and not infection may be included at the discretion of the Investigator.
- Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 90 days prior to Check-in, or within 5 half lives of the investigational drug used in the study.
- Use or intend to use slow-release medications/products considered to still be active within 30 days prior to Check-in, unless deemed acceptable by the Investigator (or designee).
- Use or intend use of any prescription medications/ nonprescription products known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 30 days prior to Check-in, unless deemed acceptable by the Investigator or designee.
- Use or intend to use any nonprescription medications/products including vitamins, minerals, and phytotherapeutic/herbal/plant derived preparations within 7 days prior to Check-in, unless deemed acceptable by the Investigator (or designee).
- Have received a live or attenuated vaccine from 3 months prior to Screening or have the intention to receive a vaccine during the study.
- Intend to travel to a region where a vaccination will be required due to endemic disease within 3 months of dosing.
- Previous treatment with an anti VEGF antibody or any other protein or antibody targeting the VEGF receptor.
- Use of tobacco- or nicotine-containing products within 1 year prior to Check-in, or positive cotinine test upon Screening or Check-in.
- Receipt of blood products within 60 days prior to Check-in.
- Donation of blood from 90 days prior to Screening, plasma from 14 days prior to Screening, or platelets from 42 days prior to Screening.
- Poor peripheral venous access.
- History of abnormal peripheral sensation including paraesthesia and/or numbness in arms and/or legs.
- Have previously completed or withdrawn from this study or any other study investigating bevacizumab, and/or have previously received bevacizumab.
- Subjects who, in the opinion of the Investigator (or designee), should not participate in this study.
- Vulnerable subjects (e.g. persons kept in detention).
- Subjects who are study site employees or immediate family members of a study site or Mabxience employee.
Data sourced from ClinicalTrials.gov (NCT04408989). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.